Monday, October 27, 2008

Does Tort Litigation Improve Drug Safety?

There are many eyes to the preemption storm.

But one of those eyes is surely this: Does tort litigation improve the safety of drugs?

The plaintiffs' bar screams yes: It insists that lawsuits unearth new information that protect the public.

Is that true?

We haven't seen any empirical scholarhip on this point (though, Lord knows, it might exist, and we simply haven't come across it). And it's pretty hard to research this question, given the nature of what you're looking for.

But we've found a few authorities that suggest that tort litigation rarely contributes to protecting public health.

Thus, for example, Richard Epstein recently wrote:

"The drugs that usually generate the most litigation -- such as Rezulin and Vioxx -- usually are withdrawn before litigation commences. Indeed the plaintiffs' bar rightly free rides on FDA determinations, reducing the social gain from litigation."

Richard A. Epstein, "The Case For Field Preemption Of State Laws in Drug Cases," 103 Northwestern University Law Review Colloquy 54, 59-60 (2008) (and the usual link).

Epstein's not alone. Anita Bernstein wrote last year:

"[N]ot since the litigation-hastened demise of the very dangerous Dalkon Shield intrauterine device in 1974 has any pharmaceutical product demonstrated that personal-injury liability can be a source of social utility. Take Vioxx as an exemplar of what personal-injury liability has not achieved. Plaintiffs' lawyers did not discover its dangers; the drug had already left the market before a jury verdict came in against it; increases in talk about improving drug safety policy also had predated liability for this drug; and personal-injury litigation did not generate information to benefit the consuming public."

Anita Bernstein, "Enhancing Drug Effectiveness and Efficacy Through Personal Injury Litigation," 15 J.L. & Pol'y 1051, 1055 (2007) (here's a link through Hein Online, but we're not sure if everyone will be able to click through it). (Note that we disagree with Bernstein's suggestion that the solution is to increase tort liability on manufacturers. We cite the piece only for its recognition that the current state of tort law seemingly does little to improve drug safety.)

Peter Schuck writes, in a forthcoming article in the Roger Williams University Law Review:

"FDA regulation of drug risks is subject to many monitoring institutions, both specialized and generic, other than tort law. In this specific area, it would be surprising indeed if lay plaintiffs' lawyers originated this information -- as distinguished from marshalling and shaping information unearthed by others into more focused, tendentious forms for litigation purposes."

Peter H. Schuck, "FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot," __ Roger Williams University Law Review __ (2009) (available at SSRN here).

This leaves us with a thought and a suggestion:

The thought: If it hasn't already been done, someone should undertake some empirical research on this question. The result could be an important piece that could inform public policy.

And the suggestion: Until the empirical data exist, defendants should not concede that pharmaceutical tort litigation improves the public health. What little we've found on the subject suggests that it does not.


Eric Turkewitz said...

The fact that a product (drug or otherwise) is withdrawn before litigation does not mean that the tort system isn't working.

For the very real concern among manufacturers that they will be held accountable one day for bad products still exists. How one would do an empirical analysis of a board room discussion about product risks remains unclear, since there would seem to be way too many variables (amongst other problems).

MaxKennerly said...

Why, pray tell, are pharmaceuticals so quick to withdraw these drugs when a problem is discovered? Maybe, just maybe, to avoid further civil liability?

Indeed, without tort litigation there would be no consequences at all to squeezing a little (or a lot) more profit out until the manufacturer reached the point of criminal liability.

I'd call that "unsafe."

Mark Pruner said...

Another major benefit of the tort litigation system is that it brings to public and press view inappropriate actions and conflicts of interests by the FDA and the other regulators. The drug industry spends millions of dollars every year on building relationships with the regulators. They wouldn't be doing it if they didn't think it gave them an advantage.

Also the drug companies may not forward info to the FDA on a timely basis. So drugs get pulled late from the market. The drug company lawyers know that this kind of obfuscation and cover-up will result in much higher tort damages.

Anonymous said...

The real question is aw Scalia put it in a speach to FDLI in March. "How much government can we afford?" Can we afford duplicate functions in the judiciary and executive branches, and at the State, Federal and now international (WHO) levels? Of course dual oversight is more effective, but at what cost to society?

If IP and profits are continually reduced, investors won't take the risks of developing novel therapies either.